This company is well resourced and financed with significant growth plans. Be part of a company who has established itself as a fully integrated biopharmaceutical company, ranging from cell line development of biosimilars to manufacturing, clinical development and registrations. Their manufacturing process is based on 1,000L and 2,000L single use bioreactor fermentation design and has a total capacity of 16,000L and is run almost totally on renewable energy.
As a team leader in upstream process development, you will be supervising a team of scientists and you are responsible for providing technical and scientific leadership and guidance to the USP development team to ensure efficient development and characterisation of an upstream process.
- Write/ review/ approve appropriate SOPs, technical documents, reports and other GMP documentations
- Support technology transfer with manufacturing (internal and external), scale up/down, troubleshooting and regulatory submissions
- Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required
- Maintaining leading-edge knowledge and understanding of new technologies in the field of USP process development and proactively share knowledge with the team
- Ensure USP development labs and equipment are maintained in orderly fashion
- Minimum of 5 years’ experience in biopharmaceuticals or technical field desired
- Knowledge of upstream development activities (lab scale and production scale) including hands-on expertise operating upstream equipment
- Demonstrated ability to lead, manage and motivate people and their activities
- Experience with fed-batch and perfusion mode
- Experience with screening experiments (Ambr or comparable)
- Experience in harvesting techniques
- Understanding of scale up / scale down